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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039208 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer |
Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0-1 vs 2), and line of treatment (first vs second). Patients are randomized to receive irinotecan at 1 of 6 different times of the day.
Patients receive irinotecan IV over 6 hours on day 1 and fluorouracil IV and leucovorin calcium IV over 11 hours followed by oxaliplatin IV over 11 hours on days 2-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A maximum of 186 patients (31 per irinotecan administration time) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Belgium | |
Centre Hospitalier Notre Dame - Reine Fabiola | |
Charleroi, Belgium, 6000 | |
Centre Hospitalier Peltzer-La Tourelle | |
Verviers, Belgium, B-4800 | |
CHU Liege - Domaine Universitaire du Sart Tilman | |
Liege, Belgium, B-4000 | |
Clinique Sainte Elisabeth | |
Namur, Belgium, 5000 | |
Clinique Saint-Joseph | |
Liege, Belgium, B 4000 | |
France | |
Hopital Paul Brousse | |
Villejuif, France, 94804 | |
Centre Hospital Regional Universitaire de Limoges | |
Limoges, France, 87042 | |
Centre Jean Perrin | |
Clermont-Ferrand, France, 63011 | |
Centre Rene Huguenin | |
Saint Cloud, France, 92211 | |
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
Dijon, France, 21079 | |
Hopital Saint-Louis | |
Paris, France, 75475 | |
Italy | |
Azienda Ospedale S. Luigi at University of Torino | |
Orbassano, (Torino), Italy, 10043 | |
Azienda Sanitaria di Bolzano | |
Bolzano, Italy, 39100 | |
Fondazione Salvatore Maugeri | |
Pavia, Italy, I-27100 | |
Istituto Clinico Beato Matteo | |
Vigevano, Italy, 27029 | |
Istituto Regina Elena | |
Rome, Italy, 00161 | |
Ospedale Oncologico Regionale | |
RIONERO in VULTURE, Italy, I-58028 | |
Ospedale San Carlo Borromeo | |
Milano (Milan), Italy, 20153 | |
Universita G.D'Annunzio Di Chieti | |
Chieti, Italy, 66100 | |
Portugal | |
Hospital Fernando Fonseca | |
Amadora, Portugal, P-2700 |
Investigator: | Carlo Garufi, MD | Istituti Fisioterapici Ospitalieri - Roma |
Study ID Numbers: | CDR0000069363, EORTC-05011 |
Study First Received: | June 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00039208 History of Changes |
Health Authority: | United States: Federal Government |
stage III colon cancer stage IV colon cancer stage III rectal cancer |
stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Leucovorin Rectal Diseases Signs and Symptoms Oxaliplatin Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex |
Rectal Neoplasm Trace Elements Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Camptothecin Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Irinotecan Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |